Sorrento Announces the Full Enrollment of the Pivotal Phase 3 Trial with Olgotrelvir (OVYDSOTM) (STI-1558), a Second Generation Oral Mpro Inhibitor, as a Standalone Treatment for COVID-19
- The Phase 3 study of Ovydso was initiated in China in February 2023 and enrolled and dosed 1,200 COVID-19 patients (1:1, active:placebo) at 25 sites in China.
- During the trial, Ovydso has maintained an excellent safety profile with no Grade 3 toxicities reported.
- We anticipate top line data in the third quarter of this year.
- If the trial meets its endpoints, we have agreements with the China Health Authority (National Medical Products Administration, or NMPA) for a fast review of the application based on this Phase 3 trial.
- Should the Phase 3 trial be successful, we plan to open dialogue with regulatory agencies around the world to discuss paths to approval.
SAN DIEGO, June 26, 2023 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (OTC: SRNEQ) announced today the full enrollment in a pivotal Phase 3 study of Sorrento’s oral Mpro inhibitor, Ovydso (STI-1558), in mild or moderate symptomatic adults infected with SARS-CoV-2, or COVID-19.
The Phase 3 study (MPR-COV-301CN) is entitled: “A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study Evaluating the Efficacy and Safety of STI-1558 in Adult Subjects With Mild or Moderate (COVID-19)”. The Phase 3 study has enrolled 1,200 patients with COVID-19. After communications with the NMPA, a consensus was reached on the primary endpoint and the key secondary endpoint, which are the time to recovery for 11 key COVID-19 symptoms and the viral RNA copy load reduction in comparison with the baseline, respectively. The study was conducted at 25 sites in China, led by Dr. Hongzhou Lu, Fellow of the American Society for Microbiology, Professor and Dean of Shenzhen Third Hospital and co-led by Dr. Ronmeng Jiang, Professor and Deputy Dean of Beijing DiTan Hospital.
As the dosing of the last patient is complete and due to the nature of the trial (5 days of treatment), Sorrento has been cleaning the database throughout the duration of the trial and expects to have the database fully cleaned and locked in August 2023. Sorrento anticipates top line data from the study in the third quarter of this year.
With the completion of enrollment for this trial, Sorrento has treated almost 1,450 volunteers and patients. Once the data is finalized, Sorrento plans to open discussions with regulatory authorities worldwide to discuss the path required for each particular authority for a full approval of Ovydso.
“We are pleased to see that Ovydso has enrolled quickly for a successful completion of enrollment for the phase 3 pivotal trial in China. We look forward to seeing the final data and to working closely with the NMPA during the review to evaluate this as a potential stand-alone treatment for COVID-19 patients as rapidly as possible,” stated Henry Ji, Ph.D., Chairman and CEO of Sorrento.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease, and COVID-19. Sorrento’s multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as next-generation tyrosine kinase inhibitors (“TKIs”), fully human antibodies (“G-MAB™ library”), immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including STI-1558 and COVI-MSC™, and diagnostic test solutions, including COVIMARK™.
Sorrento’s commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a TRPV1 agonist, non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of postherpetic neuralgia (PHN). RTX has been cleared for a Phase II trial for intractable pain associated with cancer and a Phase II trial in osteoarthritis patients. Positive final results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. ZTlido® was approved by the FDA on February 28, 2018.
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Forward-Looking Statements
This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Sorrento’s products, technologies and prospects, Sorrento’s expectations regarding the timing of its database to be fully clean and locked and the timing for the top line data, the possibility of rapid review by the NMPA of the application based on the Phase 3 trial and Sorrento’s plan to open dialogue and discussions with regulatory authorities worldwide to discuss the paths to approval of Ovydso. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento’s technologies and prospects, including, but not limited to risks related to safety and efficacy of Ovydso and seeking regulatory approval for Ovydso; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks that prior test, study and trial results, including those for Ovydso, may not be replicated in continuing or future studies and trials; risks of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in the execution of its product candidates’ strategies; risks relating to the voluntary proceedings under Chapter 11 in the Bankruptcy Court (the “Chapter 11 Cases”), Sorrento’s ability to continue operating in the ordinary course while the Chapter 11 Cases are pending, the timing and outcome of the Chapter 11 Cases, Sorrento’s ability to obtain timely approval by the Bankruptcy Court of the motions filed in the Chapter 11 Cases, employee attrition and Sorrento’s ability to retain senior management and other key personnel due to the distractions and uncertainties of the Chapter 11 Cases, Sorrento’s ability to maintain relationships with suppliers, customers, employees and other third parties and regulatory authorities as a result of the Chapter 11 Cases, the Bankruptcy Court’s rulings in the Chapter 11 Cases, the length of time that Sorrento will operate under Chapter 11 protection and the continued availability to Sorrento of operating capital during the pendency of the Chapter 11 Cases, risks associated with any third party motions in the Chapter 11 Cases, increased administrative and legal costs related to the chapter 11 process, exposure to potential litigation and inherent risks involved in a bankruptcy process, the potential adverse effects of the Chapter 11 Cases on Sorrento’s liquidity or results of operations, or Sorrento’s ability to timely file its periodic reports or meet periodic reporting requirements with the SEC; and other risks that are described in Sorrento’s most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento’s Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release except as required by law.
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